The news follows the positive drug reimbursement recommendation for Erelzi from the Canadian Drug Expert Committee (CDEC) as part of the Common Drug Review (CDR). Health Canada granted Erelzi a Notice of Compliance in April 2017.

Erelzi is a biosimilar of Amgen/Pfizer’s Enbrel (etanercept). The biosimilar application for Erelzi included data from Sandoz’s EGALITY study [1], which ‘has shown that Erelzi is safe and effective, and switching patients from Enbrel to Erelzi can be performed safely without any loss of efficacy’, according to Dr Janet Pope, Professor of Medicine in the Division of Rheumatology, Epidemiology, and Biostatistics at the University of Western Ontario, Schulich School of Medicine, London, Ontario, Canada.

Erelzi has been approved in Canada for the treatment of ankylosing spondylitis and moderately to severely active rheumatoid arthritis in adults, as well as polyarticular juvenile idiopathic arthritis in patients aged 4 years or older.

Erelzi is the second etanercept biosimilar to be approved by Health Canada. Merck Canada’s Brenzys (etanercept) was the first etanercept biosimilar to be approved by the agency back in August 2016 [2]. Brenzys, however, is only approved for ankylosing spondylitis and rheumatoid arthritis, and not for juvenile idiopathic arthritis. Sandoz states that Erelzi is the ‘first biosimilar approved to treat juvenile idiopathic arthritis’.

Sandoz also has a somatropin biosimilar approved in Canada. Omnitrope (somatropin) was approved for the treatment of growth hormone deficiency in adults and children in April 2009 [2].

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